NCT05569278

Safety and Pharmacokinetics of GEH200486 in Healthy Volunteers

A Phase 1 Single Centre, Single Ascending Dose Safety Study of GEH200486 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a single center, prospective, dose escalation study (4 different dose levels) for a novel magnetic resonance imaging (MRI) contrast agent, in male and female healthy volunteers . The study is primarily designed to collect safety data. In addition, researchers want to learn more about how the novel contrast agent, GEH200486 circulates and is eliminated from the body (pharmacokinetics) after injection in healthy volunteers. Up to 24 healthy volunteers will be enrolled and will each receive a single administration of one of the 4 doses of GEH200486. Each healthy volunteer will stay at the clinical unit for the first 24 hours post injection and return for up to 3 follow-up visits with 1 additional follow-up phone call. Dose escalation from one dose group to the next dose group will be sequential and only be allowed if the clinical safety of all healthy volunteers from the tested dose group is acceptable, as assessed by an independent safety committee, members of GEHC team and the principal investigator.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	GE200486 0.5M Injection	Single administration by intravenous (IV) hand injection without dilution, followed by a 5mL saline flush

Timeline

• Start date: 2022-08-22
• Primary completion: 2022-11-29
• Completion: 2022-11-29
• First posted: 2022-10-06
• Last updated: 2023-07-06

Locations

1 site across 1 country: Norway